BANDANA mit Stoffanteilen, lang mit Zwickel
by Werkmeister GmbH + Co. KG 2 variants
Ref 13ALGZW, 10ZW
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4048486231101YC | Date1 Sep 2025 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- BANDANA mit Stoffanteilen, lang mit ZwickelBANDANA mit Zwickel
- Device Name
- Rumpfstützorthese
- Model / Reference
- 13ALGZW, 10ZW
- Primary DI / UDI-DI
- 04048486073251, 04048486073206, 04048486073169, 04048486072445, 04048486073183, 04048486073237, 04048486073176, 04048486073213, 04048486073268, 04048486073190
- Basic UDI-DI
- 4048486231101YC
- Direct Marketing DI
- 04048486073251040484860732060404848607316904048486072445040484860731830404848607323704048486073176040484860732130404848607326804048486073190
- EMDN Code
- Y060499 Abdominal orthoses - other
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- DE-MF-000005120
Other devices from Werkmeister GmbH + Co. KG
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No